SPRINT Endura, Shipping ConfigurationRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00854001007588), received between Nov 6, 2020 and Sep 28, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient experienced a Staphylococcal infection in their shoulder joint and an Infectious Disease physician evaluating the patient further suspected that the patient was septic. The patient was hospitalized, prescribed antibiotics including the placement of a PICC line, a joint washout procedure was performed, and their lead was removed prior to the planned end of treatment.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 50916269 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient's lead was removed due to full body rash. Area under mounting pad was raw, irritated, with oozing blisters. The day after lead removal, the severity of the blisters on the patient's foot increased to the point of interferring wiht their ability to walk. Patient was prescribed antibiotics and both oral and topical steroids as well as washing the affected areas with a hypochlorous acid-based wound care solution (Puracyn). Patient followed up with a dermatologist, allergist, and rheumatology.

  Patient problems: Ambulation or Postural Difficulties; Blister; Pain; Rash

  MAUDE report 50715449 ↗
• InjuryJul 29, 2026Fracture

  Patient had a lead fracture and experienced pain and a suspected infection. Patient was hospitalized for surgical removal of the lead and was prescribed IV antibiotics.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50068428 ↗
• InjuryMar 26, 2026Fracture

  PATIENT EXPERIENCED A LEAD FRACTURE ULTIMATELY RESULTING IN THE NEED FOR SURGICAL REMOVAL OF THE REMNANT DUE TO INFECTION AND INCREASED DISCOMFORT AND SWELLING.

  Patient problems: Bacterial Infection; Granuloma; Pain

  MAUDE report 24699182 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN INFECTION AND ADMINISTERED INTRAVENOUS (IV) ANTIBIOTICS. THE PATIENT'S LEADS WERE REMOVED. THE PATIENT REPORTED EXPERIENCING COMPLICATIONS SUCH AS CONTINUED SWELLING OF THE AREA SURROUNDING THE LEAD EXIT SITE, BLISTERING, AND INFECTION SPREADING TO THEIR BLOODSTREAM REQUIRING ADDITIONAL ANTIBIOTICS TO BE ADMINISTERED. A DEBRIDEMENT PROCEDURE WAS PERFORMED FOR ADDITIONAL TREATMENT OF THE ISSUE.

  Patient problems: Bacterial Infection; Blister; Pain; Swelling/ Edema

  MAUDE report 24445279 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED ERYTHEMA, AND TENDERNESS THREE WEEKS POST-IMPLANTATION. PATIENTS LEAD WAS REMOVED BUT DESPITE DEVICE EXPLANATION, ULCERATION PROGRESSED, AND THE PATIENT WAS HOSPITALIZED WITH AN INFECTION. INTERVENTIONS INCLUDED SURGICAL DEBRIDEMENT, BALLOON ANGIOPLASTY, AND IV ANTIBIOTICS FOLLOWED BY ADDITIONAL ORAL ANTIBIOTICS.

  Patient problems: Bacterial Infection; Erythema; Pain; Ulcer

  MAUDE report 24326521 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED SORENESS AND PURULENT DISCHARGE AT THEIR LEAD EXIT SITE. THE PATIENT'S LEAD WAS REMOVED AND AN INCISION AND DRAINAGE PROCEDURE WAS PERFORMED TO ADDRESS THE PURULENT DISCHARGE PRESENT AT THE SITE. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS.

  Patient problems: Abscess; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22144381 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INFECTION THAT REQUIRED A SURGICAL DEBRIDEMENT, LEAD REMNANT REMOVAL, ANTIBIOTICS, AND HOSPITAL ADMISSION.

  Patient problems: Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 21763454 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED AN INFECTION NEAR HER LEAD EXIT SITE. PATIENT'S LEAD WAS REMOVED IN THE ED AND ANTIBIOTICS WERE PRESCRIBED. THE SITE WAS LANCED, DRAINED, AND PACKED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21662170 ↗
• InjuryFeb 18, 2025Fracture; Fracture

  PATIENT'S LEAD FRACTURED UPON EXPLANT. PATIENT WAS REFERRED TO A SURGEON FOR REMOVAL OF THE REMNANT AS HE REPORTED PAIN AT THE LOCATION OF THE REMNANT. ANTIBIOTICS WERE PRESCRIBED AS A PRECAUTION.

  Patient problems: Pain

  MAUDE report 21400849 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED AN INFECTION AT THEIR LEAD EXIT SITE ALONG WITH AN ABSCESS. PATIENT'S LEAD WAS REMOVED, THE ABSCESS WAS INCISED, DRAINED, AND PACKED, AND BOTH ORAL AND IV ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: Abscess; Blood Protein Abnormal; High White Blood Cell Count; Unspecified Infection

  MAUDE report 21393550 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED EXCESSIVE FLUID BUILD UP IN THE AREA OF THEIR MEDIAL GENICULAR LEAD. THE PATIENT'S LEADS WERE REMOVED DUE TO INFECTION CONCERNS AND PAIN RESULTING IN DIFFICULTY WALKING. FLUID WAS ASPIRATED FROM THE PATIENT'S KNEE ON THREE SEPARATE OCCASIONS IN ASSOCIATION WITH THIS ISSUE, INCLUDING AT THE TIME OF EACH LEAD'S REMOVAL.

  Patient problems: Ambulation or Postural Difficulties; Fluid Discharge; Pain

  MAUDE report 19532228 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S KNEE BECAME INFECTED DURING TREATMENT WITH THE SPRINT PNS SYSTEM. THE LEADS WERE REMOVED AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. PATIENT WAS HOSPITALIZED A WEEK LATER AND HIS ARTIFICIAL KNEE JOINT WAS REMOVED BECAUSE OF THE INFECTION.

  Patient problems: Ambulation or Postural Difficulties; Unspecified Infection

  MAUDE report 18510595 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED SWELLING AND FLUID AROUND THE LEAD EXIT SITE. THE LEAD WAS REMOVED AND THE PATIENT EXPERIENCED SHORTNESS OF BREATH BEGINNING THE DAY OF LEAD REMOVAL. THE PATIENT REPORTEDLY COLLAPSED AND WAS UNABLE TO WALK THE DAY AFTER LEAD REMOVAL AND WAS ADMITTED TO THE HOSPITAL AFTER BEING TAKEN TO THE EMERGENCY ROOM. THE PATIENT EXPERIENCED FLUID COLLECTION IN OTHER AREAS OF THE BODY IN ADDITION TO WHERE THE LEAD HAD BEEN (IN HER LEG) AND WAS SCHEDULED FOR A PLEUROCENTESIS PROCEDURE WHILE HOSPITALIZED. THE PATIENT RECEIVED INTRAVENOUS (IV) ANTIBIOTICS THROUGH A PICC LINE. THE PATIENT'S KNEE REPLACEMENT HARDWARE WAS REMOVED DURING THE PATIENT'S HOSPITALIZATION DUE TO LOOSENING OF THE JOINT. THE PATIENT'S SPOUSE ADDITIONALLY REPORTED THAT THE PATIENT BEGAN EXPERIENCING DECREASED BLOOD PRESSURE AND THE ONSET OF KIDNEY FAILURE DURING HER HOSPITAL ADMISSION. IT IS UNKNOWN IF THESE ISSUES ARE RELATED TO THE DEVICE.

  Patient problems: Ambulation or Postural Difficulties; Fluid Discharge; Low Blood Pressure/ Hypotension; Pleural Effusion; Renal Impairment; Swelling/ Edema; Unspecified Infection

  MAUDE report 17703662 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTEDLY EXPERIENCED DRAINAGE FROM THE LEAD EXIT SITE ON THEIR ANKLE ALONG WITH SWELLING, SKIN IRRITATION (I.E., REDNESS) WHERE THE EDGE OF THE ADHESIVE OR NON-ADHESIVE PORTION OF THE WATERPROOF BANDAGE PRESUMABLY WAS, AND BROKEN SKIN SURROUNDING THE LEAD EXIST SITE. ANTIBIOTICS WERE PRESCRIBED FOR TREATMENT OF THE IRRITATION. THE PATIENT WAS SEEN BY THEIR PHYSICIAN FOR EVALUATION OF THE ISSUE AND BOTH LEADS WERE REMOVED PRIOR TO THE PLANNED END OF TREATMENT DATE. THE PATIENT WAS SENT FROM THEIR PHYSICIAN'S OFFICE TO THE EMERGENCY ROOM (ER) FOR FURTHER EVALUATION OF THE ISSUE. THERE HE RECEIVED INTRAVENOUS (IV) ANTIBIOTICS AS WELL AS ADDITIONAL PRESCRIBED ORAL ANTIBIOTICS FOR CONTINUED TREATMENT OF THE ISSUE.

  Patient problems: Fluid Discharge; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17429851 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTEDLY EXPERIENCED PAIN AND SORENESS AT THE EXIT SITE FOR THEIR LEAD TARGETING THE LEFT L3 MEDIAL BRANCH OF THE DORSAL RAMUS. THE PATIENT WENT TO THE LOCAL EMERGENCY ROOM (ER) FOR ASSESSMENT OF THE ISSUE AND WAS SUBSEQUENTLY HOSPITALIZED FOR APPROXIMATELY 3 DAYS DUE TO INFECTION OF THE AFFECTED LEAD. THE PATIENT'S IMPLANTING PHYSICIAN REPORTEDLY ELECTED TO REMOVE THE AFFECTED LEAD ON THE SECOND DAY OF THE PATIENT'S HOSPITALIZATION AND NOTED PURULENT DISCHARGE (I.E., PUS) ON THE LEAD DURING REMOVAL. WHILE HOSPITALIZED, THE PATIENT REPORTEDLY RECEIVED INTRAVENOUS ANTIBIOTICS AND WAS PRESCRIBED ORAL ANTIBIOTICS FOR FURTHER TREATMENT OF THE ISSUE.

  Patient problems: Purulent Discharge; Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 17408294 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECIEVED A STIMULATING LEAD IN HER BRACHIAL PLEXUS PRIOR TO SHOULDER SURGERY. THE SURGEON PERFORMING THE SHOULDER SURGERY REQUESTED THE LEAD BE PLACED IN A DIFFERENT LOCATION THAN WHERE THE BRACHIAL PLEXUS LEADS ARE TYPICALLY PLACED. THE LEAD ENDED UP RIGHT UNDER THE SHOULD SLING STRAP. PATIENT COMPLAINED OF PAIN AND WAS PUT ON DOXYCYCLINE. PATIENT STILL COMPLAINED OF PAIN AND WAS BROUGHT IN FOR LEAD REMOVAL. THEY BROUGHT HER TO THE EMERGENCY DEPARTMENT AND PUT HER UNDER GENERAL ANESTHESIA OR SEDATION (UNKNOWN DUE TO CONFLICTING ACCOUNTS) TO REMOVE THE LEAD. SHE COMPLETED HER 10-DAY COURSE OF DOXYCYCLINE AND WAS THEN COMPLETELY SYMPTOM/SIGN FREE.

  Patient problems: Skin Infection; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 14471785 ↗
• InjuryJul 1, 2021Fracture; Fracture

  LEAD FRACTURED DURING EXPLANT. THE PA TRIED FOR 45 MIN TO MASSAGE THE TISSUE AROUND THE LEAD AND PULL IN A CIRCULAR MOTION AND IN DIFFERENT DIRECTIONS BUT IT EVENTUALLY FRACTURED. DAYS AFTER THE LEAD WAS EXPLANTED THE PATIENT SENT PICTURES OF A SWOLLEN NODE NEAR WHERE THE LEAD WAS PULLED. THE NODE GREW IN SIZE AND HE SOUGHT OUT A SURGEON TO REMOVE THE FRACTURED LEAD REMNANT. PATIENT WAS PLACED ON ANTIBIOTICS.

  Patient problems: Device Embedded In Tissue or Plaque; Nodule; Unspecified Infection

  MAUDE report 12101101 ↗
• MalfunctionMar 26, 2021Fracture; Fracture

  AS REPORTED: SPR PERIPHERAL NERVE STIMULATOR LEAD WAS REMOVED DURING OFFICE VISIT AND PATIENT TOLERATED THE LEAD REMOVAL WITHOUT ISSUE. IT WAS NOT ENTIRELY CLEAR IF THE LEAD TIP WAS INTACT. RIGHT SIDED PELVIC X-RAY ORDERED TO POSSIBLY DETERMINE IF LEAD TIP IS INDEED RETAINED. SPR DEVICE REP NOTIFIED AS WELL. PATIENT GIVEN MRI SAFETY CARD IN THE EVENT HE WOULD NEED TO HAVE THIS FOR THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576614 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SOME BLEEDING DURING PERCUTANEOUS PLACEMENT OF A MICROLEAD IN THE SCIATIC POPLITEAL AREA. AFTER THE PROCEDURE THE PATIENT INDICATED THAT HE HAD SOME PAIN IN THE AREA. THE PATIENT HAD PAIN OVERNIGHT AND WENT TO THE HOSPITAL WITH A HEMATOMA THE MORNING AFTER THE PROCEDURE. THE IMPLANTING PHYSICIAN WAS AWARE AND HAD BEEN SEEING THE PATIENT IN THE HOSPITAL. THEY HAD STOPPED HIS COUMADIN AND HE WAS STABILIZED. PATIENT HAD NOT BEEN USING THE STIMULATOR AND THE MICROLEAD WAS REMOVED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10801454 ↗